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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Medsafe Updates Recall Process Following Public Consultation

New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its drug and medical device recall process. The document is far more comprehensive than the one it replaces, notably because it includes additional information about how to decide on and execute recalls.

Medsafe released a draft of the document for consultation late last year, and the version that is now coming into force takes into account the 43 feedback submissions it subsequently received. The feedback led Medsafe to make some small changes to the document. A diagram has been altered to make it clearer and some text has been tweaked to avoid confusion between the classes of recalls and those used in the Web Assisted Notification of Devices (WAND) Database.

The changes address some of the concerns raised by the 25% of respondents who said they would only be in favor of adopting the code if it was amended. However, some of the changes proposed are beyond the powers of Medsafe. Proposals to use specific software systems such as GS1 New Zealand, for example, were knocked back because Medsafe is unable to endorse technologies. Other proposals, such as a move away from using fax technology, were also rejected.

While the tweaks made by Medsafe will address some of the industry's concerns, the version that is due to come into force on 1 December is unlikely to satisfy a significant minority of people. Almost 25% of respondents were against adopting the code. This group criticized the recall code for lacking provisions to recompense pharmacists and physicians for their role in recalls. Others who are against the code called the process too inconsistent, rigid and slow to be effective.

Japan Chastises Pfizer for Failing to Report Adverse Events

Japan's Ministry of Health, Labor and Welfare (MHLW) has told Pfizer to improve its adverse event monitoring and reporting process. The order follows the discovery that Pfizer failed to report 212 adverse events for 11 products within the allotted timeframe.

Pfizer took up the issue with MHLW in February after noticing that it may have fallen behind with the reporting of side effects for cancer drugs, in-PharmaTechnologist.com reports. The timing of the initial interaction between Pfizer and MHLW coincides with when Japanese officials were finalizing the punishment of Novartis for its failure to report more than 3,000 adverse events. Novartis received a temporary ban on producing and selling drugs in Japan for its compliance failings.

MHLW has taken a softer line on Pfizer. The company can continue to operate as usual in Japan, but must take steps to cut the risk of it failing to meet its reporting requirements in the future. "Pfizer Japan shall improve certain business operation procedures regarding safety reporting, and provide a re-training to all company employees to ensure that they understand their obligations regarding adverse event reporting," a Pfizer representative said.

Proportion of Staff Recommending TGA as a Good Place to Work falls by 10%

Australia's Therapeutic Goods Administration (TGA) has reported 58% of its staff now recommends it as a good place to work. The figure represents a 10% drop on the two previous years, when 65% of TGA staff recommended their employer.

The decline mirrors the trend across all public service sectors in Australia. Recommendations among this broader group have declined by at least three percentage points each year since 2013, culminating in the proportion recommending their employer as a good place to work falling to 55% this year. The decline coincides with the period in which Tony Abbott has led the country and pushed an austerity agenda.

While the results suggest the agenda is having an effect on morale at TGA, only a minority of polled employees have a negative view of the organization. Neutral trailed positive as the second most popular response among the 506 polled employees with 29% of the votes. The data suggest 13% of respondents have a negative perception of TGA as a place to work. TGA has stopped asking staff whether they think the work they do is important for public health.

Assocham Pleads with Indian Government for Changes to Clinical Trial Regulations

The Associated Chambers of Commerce and Industry of India (Assocham) is pleading with the health ministry for changes to the regulation of clinical trials. Many of Assocham's concerns center on the contentious compensation scheme for people who suffer injuries while participating in research.

As Assocham sees it, the compensation program is flawed, notably because of how broadly "trial related injury" is defined and how quickly processes must be followed after a serious adverse event occurs. Assocham called the timelines "strict and unreasonable." The trade association has issues with the criteria used to assess whether a person is eligible for compensation, too. Assocham detailed its grievances in a letter sent to the Indian health and pharmaceutical ministries.

In a press release to outline the letter, Assocham also took aim at the perceived weaknesses of the Central Drugs Standard Control Organization (CDSCO) and the propagation of myths about clinical trials. Assocham wants CDSCO to hire experienced personnel so it can review clinical trial filings faster. To address the perception of clinical trials in India, the trade association has called for a push to raise awareness in parliament, the media, the judiciary and among law making authorities.

China Approves 3D-Printed Hip Joint

China has approved a 3D-printed medical device for the first time. The regulatory acceptance of the approach has given researchers the confidence to look beyond the approval of the hip joint and to an era in which China is a leader in 3D-printed medical devices, South China Morning Post reports.

Officials at China Food and Drug Administration (CFDA) signed off on the approval late last month, since when the industry has begun to digest the implications of the regulatory precedent. In the near term, the approval may affect the 300,000 people who need a hip implant in China every year. Foreign medical device manufacturers service this market, but could find themselves undercut by implants printed at Chinese hospitals.

In the longer term, the team behind the CFDA-approved hip implant expects to see 3D printing affect other areas of healthcare. "This is just the beginning. Approval for other 3D-printed implants will be accelerated and announced soon. In this field [China] will not follow other countries, but will be first and lead the world," Liu Zhongjun, an orthopedist who worked on the project, told CCTV.

Other News:

A court in India has rejected a patent covering Pfizer's rheumatoid arthritis drug Xeljanz. The dispute relates to whether the formulation used by Pfizer warrants intellectual property protection beyond that afforded to the active ingredient. Pfizer is considering its options following the setback, which is the latest in a string of blows dealt by the Indian courts to Western drugmakers. Reuters

India's Drug Technical Advisory Board (DTAB) has rejected a proposal to make the National Institute of Biologicals (NIB) a Central Drug Laboratory for vaccine testing. NIB is already a notified lab for the testing of a range of biologics, but DTAB has come out against a government proposal to expand its remit. Currently, only a lab in the town of Kasauli is authorized to test vaccines. PharmaBiz